ANDA 071061

YAOPHARMA CO LTD

FDA Drug Application

Application #071061

Application Sponsors

ANDA 071061

YAOPHARMA CO LTD

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

25MG;80MG

0

PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1987-08-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1988-10-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1988-10-13
LABELING; Labeling	SUPPL	5	AP	1989-06-27
LABELING; Labeling	SUPPL	6	AP	1991-11-25
LABELING; Labeling	SUPPL	7	AP	1992-03-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1995-03-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1998-12-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1998-12-31
LABELING; Labeling	SUPPL	11	AP	1998-09-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2001-05-09
LABELING; Labeling	SUPPL	15	AP	2020-08-06	STANDARD
LABELING; Labeling	SUPPL	16	AP	2020-08-20	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	15	Null	7
SUPPL	16	Null	7

CDER Filings

YAOPHARMA CO LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 71061
            [companyName] => YAOPHARMA CO LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE","strength":"25MG;80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE","actionType":"25MG;80MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)